Whenever a new COVID-19 variant emergences, health authorities have had limited options to fight back with other than more restrictions or boosters of authorized shots such as those from Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) or Moderna (NASDAQ: MRNA). However, these current jabs target the initial strain of the virus. Both Pfizer and Moderna are working on Omicron-specific injections, whereas there’s also been a push for a universal variant-proof COVID vaccine. Last December, it was announced that the US Army was developing a single vaccine against all COVID and SARS variants. Multiple biotech players have been working on a more flexible option including BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), and Sorrento Therapeutics, Inc. (NASDAQ: SRNE).
In collaboration with The Ohio State University, clinical stage biotech company BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) recently announced bioproduction of its newly developed vaccine BVX-1021 for the strain of coronavirus that causes Severe Acute Respiratory Syndrome (“SARS1”), the respiratory illness responsible for the deadly 2002–2004 pandemic. There are no vaccines approved for SARS1.
BVX-1021 is a hapten-modified recombinant S-protein from SARS-CoV-1, whereas BVX-0320, BioVaxys’ Covid-19 vaccine, is a hapten-modified recombinant S-spike protein from SARS-CoV-2, the virus which causes Covid-19.
BVX-0320 comprises a portion of the SARS-CoV-2 spike protein that’s modified by the hapten, dinitrophenyl (DNP); hapten modification prevents ACE2 binding while retaining immunogenicity.
The ongoing research collaboration is part of BioVaxys’ novel approach for a universal vaccine that can treat a broad range of sarbecoviruses—aka a pan-sarbecovirus vaccine.
“Scientists have observed that people who survived the 2002-03 SARS pandemic and then were administered a Covid-19 vaccine developed antibodies that cross-reacted with all of the sarbecoviruses that they tested,” said Dr. David Berd, Chief Medical Officer of Biovaxys. “That observation suggested to us that a similar pan-sarbecovirus immune response could be generated by immunizing with haptenized spike protein from SARS1 and SARS-Cov-2, i.e., our BVX-0320 and BVX-1021 products.”
A hapten is a small molecule that stimulates an immune response when conjugated with a protein such as a virus surface antigen, but lacks antigenicity of its own. Previous studies conducted by BioVaxys in mice showed how haptenized SARS-CoV-2 spike protein elicits both, robust T cell and antibody response.
It’s a platform based on the concept of haptenization, built upon the work of immunologist and Nobel laureate Dr. Karl Landsteiner. Today, BioVaxys uses this process which “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, to stimulate a more intense immune response.
“The Covid-19 market is shifting to vaccines that will not only protect against emerging variants of SARS-CoV-2, but also for any related coronaviruses that likely may arise in the future,” said Kenneth Kovan, President & COO of BioVaxys. “BVX-1021 demonstrates that we can leverage our technology platform to create novel hapten-viral antigen vaccines to target additional markets.”
BioVaxys intends to develop BVX-1021 as a standalone “booster” targeting anyone who has been immunized with a World Health Organization-recognized Covid-19 vaccine or convalesced from a Covid-19 infection.
To date, more than 410 million people worldwide have recovered from Covid-19, and 65.7% of the global population have received at least one dose of SARS-CoV-2 vaccine, or more than 5.04 billion people.
Another clinical and commercial stage biotech company working on a universal vaccines is Sorrento Therapeutics, Inc. (NASDAQ:SRNE), who recently reported promising results with a universal chimeric mRNA COVID-19 vaccine that elicits potent neutralizing antibodies and protection against not only omicron, but delta variants as well.
“The concept of a universal mRNA vaccine is still very appealing for at least two reasons,” said Dr. Henry Ji, Chairman and CEO of Sorrento. “One is that the virus could continue accumulating more mutations to eventually nullify the effectiveness of marketed mRNA vaccines. Secondly, a universal mRNA vaccine against COVID-19 is much needed worldwide, especially in developing countries.”
During the past two years, Sorrento scientists explored various strategies to develop mRNA vaccines that can potentially provide broad and effective protection against predominant SARS-CoV-2 variants of concern (VOCs) as well as potential future variants.
Their newly designed mRNA vaccine incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein anchored on the muscle cell membrane. This modification is introduced to prevent the leakage of S1 subunit from the expressed spike protein into the blood circulation, which is known in part to potentially cause undesirable side effects in vital organ tissues following administration of the current EUA-approved mRNA vaccines.
Back in January 2022, Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) initiated a study to evaluate an Omicron-based COVID-19 vaccine in adults 18 to 55 years of age. The study draws upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.
“Emerging data indicates vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains,” said Prof. Ugur Sahin, CEO and Co-founder of BioNTech. “This study is part of our science-based approach to develop a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but with longer duration of protection.”
Recently, Pfizer applied for authorization from U.S. regulators for a fourth dose for older Americans.
Moderna also recently released interim data on the effectiveness of its vaccine for children under 6 years old, showing their shots were approximately 44% effective at preventing infection in 6 months to under 2, and about 38% effective for children 2-5 years old. The company has also asked the FDA to authorize its vaccine for children 6-11 years old.
The highly mutated omicron variant has significantly reduced vaccine effectiveness from its high-water mark of around 94% when the shots were first authorized for adults in December 2020, causing many more breakthrough infections. Now both Moderna and Pfizer are leaning towards needing Omicron-specific vaccines.
In December, a Danish study found that two doses of Moderna’s vaccine were 36.7% effective against Omicron, compared with 55.2% for Pfizer. Over the next five months, those numbers quickly plummeted, while a third Pfizer dose administered 14 to 44 days after the second shot only restored protection to 56.4% in people aged 60 or older.
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